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Clinical Trials/RBR-4d9d42n
RBR-4d9d42n
Active, not recruiting
未知

Comparative study between the effect of pharmacological and non-pharmacological measures on preoperative anxiety in pediatric patients undergoing elective outpatient surgeries: prospective, randomized, blinded study

Casa de saúde assistência médica infantil de urgência0 sitesFebruary 8, 2023

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Casa de saúde assistência médica infantil de urgência
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief Summary

Introduction: anxiety in children who will undergo surgical procedures is an occurrence described in the literature, which affects approximately 50% to 75% of children. Objectives: to compare the effect between preoperative presentation of a short film in cartoon format and the use of an oral midazolam solution, administered as preanesthetic medication, in reducing anxiety in the preoperative period of preoperative -schoolchildren submitted to circumcision surgeries. Patients and methods: clinical, controlled, prospective, randomized and blind trial, carried out in a pediatric hospital. After sample calculation, 180 children were recruited, divided equally between the three groups. Children were randomized into three groups: 1) Control group; 2) Group that used Midazolam Hydrochloride, oral solution; 3) Group that watched the video on the tablet. Preoperative anxiety was analyzed using the Yale Scale, the presence of delirium using the PAED Scale, and pain using the FLACC Scale. Results: preschoolers who watched the video were less anxious when compared to the group who received Midazolam (p-value = 0.027). Children who watched the video had lower PAED values ??when compared to the group that received Midazolam and the control group. (p-value <0.00001). A significant association was observed between the presence of anxiety and postoperative delirium in the three groups. The use of Midazolam increased hospital stay. Conclusion: the group that watched the video had lower levels of anxiety, less frequency of delirium and shorter hospital stay when compared to the group that used Midazolam Hydrochloride.

Registry
who.int
Start Date
February 8, 2023
End Date
August 5, 2022
Last Updated
2 years ago
Study Type
Intervention
Sex
Male

Investigators

Sponsor
Casa de saúde assistência médica infantil de urgência

Eligibility Criteria

Inclusion Criteria

  • Patients who will undergo circumcision; aged between 2 and 7 years; with physical status according to the American Society of Anesthesiologists (ASA) I and II

Exclusion Criteria

  • Patients with Autism Spectrum Disorder (ASD); Attention Deficit Hyperactivity Disorder (ADHD); Patients with a previous history of paradoxical effect of Midazolam or hypersensitivity to any of its components; patient with serious diseases in organs such as kidney, liver, lung, heart, brain and bone marrow; patients who use psychostimulant drugs or antidepressants
  • Serious diseases in organs such as kidney, liver, lung, heart, brain and bone marrow.
  • Use of psychostimulant or antidepressant drugs

Outcomes

Primary Outcomes

Not specified

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